Clinical Trial

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

Active, Not Recruiting Phase 2
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Record status
This record was last updated August 19, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-02-08; most recent amendment 2025-08-14.
Status change: Recruiting → Active, Not Recruiting 2025-08-14
Trial Details
NCT Number NCT05733546
Lead Sponsor COMPASS Pathways
Conditions Major Depressive Disorder
Enrollment 102 participants
Start Date 2023-01-30
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-08-19